Combination taxoid nanoemulsion with immunotherapy in cancer

Abstract

A composition of an omega-3 polyunsaturated fatty acid (PUFA)-taxoid conjugate formulated in an oil-in-water nanoemulsion (NE) drug delivery system in combination with an immune-oncology (IO) agent to enhance therapeutic efficacy in refractory cancers, such as PDAC. A method of treating cancer, by administering an effective amount of a pharmaceutical composition including an omega03 PUFA-taxoid conjugate in combination with an IO agent encapsulated in an NE drug delivery system to a subject in need of treatment, and treating cancer.

What is claimed is: 
     
       1. A method of treating cancer, including the steps of:
 administering an effective amount of a pharmaceutical composition including a PUFA-taxoid conjugate encapsulated in an oil-in-water nanoemulsion (NE) drug delivery system in combination with an immune-oncology (IO) agent which is an anti-PD-L1 antibody to a subject in need of treatment, wherein oil of the NE comprises one or more omega fatty acids; and 
 treating cancer. 
 
     
     
       2. The method of  claim 1 , wherein the cancer is highly drug resistant. 
     
     
       3. The method of  claim 1 , wherein the cancer is chosen from the group consisting of breast, ovary, lung, head and neck, colon, rectal, pancreatic, melanoma, brain, prostate, leukemia, sarcomas, thyroid, Non-Hodgkin Lymphoma, bladder, gliomas, endometrial, and renal cancer. 
     
     
       4. The method of  claim 1 , wherein the PUFA is chosen from the group consisting of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and alpha-linolenic acid (LNA). 
     
     
       5. The method of  claim 1 , wherein the PUFA-taxoid conjugate is NE-DHA-SBT-1214. 
     
     
       6. The method of  claim 1 , wherein the taxoid is chosen from the group consisting of paclitaxel, docetaxel, cabazitaxel, SBT-1213, SBT-12854, SBT-121303; SBT-1216, SBT-11033, SBT-121313, SBT-121602, cabazitaxel, SBT-1212, SBT-1217, SBT-1102, SBT-1103, SBT-1104, SBT-1106, SBT-1107, SBT-121301, SBT-121302, SBT-121304, SBT-121403, SBT-11031, SBT-11032, SBT-11034, SBT-12851, SBT-12852, SBT-12853, SBT-12855, SBT-12851-1, SBT-12851-3, SBT-12852-1, SBT-12852-3, SBT-12853-1, SBT-12853-3, SBT-12854-1, SBT-12854-3, SBT-12855-1, and SBT-12855-3. 
     
     
       7. The method of  claim 1 , wherein the oil-in-water NE includes omega-3 fatty acid-rich edible oil. 
     
     
       8. The method of  claim 7 , wherein the omega-3 fatty acid-rich edible oil is chosen from the group consisting of fish oil, flax-seed oil, pine nut oil, safflower oil, primrose oil, black currant oil, borage oil, wheat germ oil, chia oil, hemp oil, perilla oil, grape oil, squalene oil, and fungal oil. 
     
     
       9. The method of  claim 7 , wherein the omega-3 fatty acid-rich edible oil is modified with a compound chosen from the group consisting of surfactants and targeting agents.